Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUANTROLS RF

K-Number: K771940 · 1977-11-02

ApplicantOrganon, Inc.
Decision Date1977-11-02
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTROLS RF is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771940. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTROLS RF?

QUANTROLS RF is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Organon, Inc.. The 510(k) number is K771940.

When did QUANTROLS RF receive FDA 510(k) clearance?

QUANTROLS RF received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771940.

Who is the listed applicant for QUANTROLS RF?

The FDA 510(k) record lists Organon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTROLS RF?

The FDA product code for QUANTROLS RF is DHR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950861RECONSTITUTION ACCESSOREISK853388MONOSTICON UNI-DOTK842314DUOCLON COLOR-CEPTK841525OREIA II B-HCG PREGNANCY TEST KITK841602ACCURATE BETA 30 PREGNANCY TEST KITK840650B-NEOCEPT 30

View all 41 devices →

Related Devices (Code: DHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑